Bio firm Celltrion wins domestic approval to sell Remsima SC

SEOUL -- Celltrion, a bio firm in South Korea, has won domestic approval to sell Remsima SC, the subcutaneous injection of Remsima, a copy of Janssen Biotech's Remicade treating rheumatoid arthritis and Crohn's disease.

Celltrion said that the Ministry of Food and Drug Safety, a South Korean government health agency, has approved Remsima SC's efficacy in rheumatoid arthritis. Celltrion will seek additional approval for Remsima SC's efficacy in inflammatory bowel disease.

The target of Remsima SC is patients who are forced to move on to expensive secondary treatments due to resistance. Instead of an intravenous injection that takes more than two hours in hospital, patients can inject Remsima SC into the fat layer beneath the skin at home.

In November 2019, Celltrion acquired final approval to sell Remsima SC in Europe. The company plans to acquire U.S. approval in 2022.

With Remsima SC, Celltrion has adopted an aggressive strategy to secure profitability and price penetration in competition with other subcutaneous-type products such as Adalimumab, sold under the brand name of Humira, which is on the World Health Organization's List of essential medicines.